Drug Pricing Hearing Takes A Partisan Turn As Gilead’s O’Day Holds His Own
Executive SummaryRepublicans took off the gloves at House oversight hearing on PrEP, arguing Democrats are more interested in scoring political points than seeking policy solutions to high drug costs.
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US FDA's advisory committee review of Gilead’s Descovy for pre-exposure prophylaxis of HIV wasn’t exactly free of controversy. But the meeting sure went more smoothly than the first PrEP review seven years ago.
US FDA advisory committee members urge agency to hold a firm line against labeling, promotional or educational materials that suggest Descovy has better efficacy or is safer than Truvada, which will face generic competition in 2020. Panel backs HIV pre-exposure prophylaxis indication for Descovy but recommends excluding cisgender women due to lack of clinical efficacy data.